NCT04637386

Brief Summary

Adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the TAP block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

November 15, 2020

Last Update Submit

July 14, 2022

Conditions

Obstetric PainObstetric Anesthesia Problems

Keywords

transversus abdominis planeVAS; visual analogue scorewound infiltrationcesarean sectionpostoperative painanalgesia

Outcome Measures

Primary Outcomes (1)

  • degree of pain at rest and on movement (hip flexion and coughing) at 2, 4, 6, 12, and 24 hours postoperatively

    , using a visual analog scale (VAS) score for pain intensity reported on 0-10-point scale for analysis. (0 = no pain and 10 = the worst possible pain).

    24 hours

Secondary Outcomes (1)

  • measures the time to the first postoperative opioid dose

    24 hours

Study Arms (2)

TAP block group

ACTIVE COMPARATOR

A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.

Procedure: Transversus Abdominis Plane Block

LAWI group

ACTIVE COMPARATOR

40 mL of bupivacaine 0.25% was injected subcutaneously into the surgical wound (20 mL on each of the upper and lower sides) by the obstetrician before skin closure

Procedure: Local anesthetic wound infiltration

Interventions

Transversus Abdominis Plane BlockPROCEDURE

A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.

TAP block group
Local anesthetic wound infiltrationPROCEDURE

40 mL of bupivacaine 0.25% was injected subcutaneously into the surgical wound (20 mL on each of the upper and lower sides) by the obstetrician before skin closure

LAWI group

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who underwent cesarean section under spinal anesthesia.
  • Aged ≥19 years and less than 40 years.
  • Gestational age ≥ 37 Weeks.

You may not qualify if:

  • Body mass index (BMI) ≥40 kg/m2.
  • History of recent opioid exposure
  • Hypersensitivity to any of the drugs used in the study.
  • Significant cardiovascular, renal, or hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine - Cairo university

Cairo, Kasr El Ainy, 11562, Egypt

Location

MeSH Terms

Conditions

Labor PainPain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Mohammed A Taymour, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecture of obstetrics and gynecology

Study Record Dates

First Submitted

November 15, 2020

First Posted

November 19, 2020

Study Start

January 1, 2021

Primary Completion

January 30, 2022

Study Completion

February 15, 2022

Last Updated

July 18, 2022

Record last verified: 2022-07

Locations

EG(1)